Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

Cardiac Valve Surgery Clinical Trial

Official title:

Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933917
• Other study ID #: 2019-056
• Status: Completed
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: April 22, 2020

Study information

• Verified date: May 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 22, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Audlt patients ( = 18 years old);

2. elective valve surgery under cardiopulmonary bypass;

3. Preoperative hemoglobin (Hb) = 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) = 2 (possibility of blood transfusion =40%).

Exclusion Criteria:

(1)Low body weight (male: <50 kg;Female: < 45kg);(2)preoperative shock;(3)myocardial infarction within 3 months before surgery;(4)ischemic heart disease;Left main coronary artery stenosis >70%;Severe aortic stenosis (area < 0.7cm2);Severe changes in left ventricular function (ejection fraction <30%, requiring vasoactive agents to assist circulation);(5)uncontrolled hypertension;(6) severe carotid artery stenosis (>70% or with symptoms);(7) kidney failure (blood creatinine level >442 mmol/L) or dialysis treatment;(8) serum albumin level (ALB) is less than 25 g/L.(9) international standardized ratio (INR) >1.5 or platelet count <100 103/mm3;(10)Inherited/acquired coagulation function defect;(11)preoperative preparation platelet;(12) contagious or infectious diseases;(13) patient or family members refused to participate in research;(14)refused to infusion of autologous blood or allogeneic blood products

Related Conditions & MeSH terms

• Cardiac Valve Surgery

Intervention

Procedure:
• Acute Normovolemic Hemodilution
Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight(Kg)×12-15(mL/Kg);Blood to be removed was capped at: Vmax=EVB×(Hi-Hf)/Hav(EBV= estimated blood volume (male:70mL/Kg,female:65mL/Kg);Hi= initial hemoglobin ;Hf=target Hb( 10g/dL );Hav= the average of the initial and minimal allowable hemoglobin).Ensure the volume of removed blood does not exceed the upper limit and Hb =10g/dL after blood removed.

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate of subjects	The percentage of patients who completed the study	Through study completion,about 8 months
Primary	Completion rate of acute normovolemic hemodilution	The percentage of patients who complete large volume of acute normovolemic hemodilution	Through study completion,about 8 months
Primary	Additional blood transfusion beyond transfusion protocol	Nonstandard blood transfusion	Through study completion,about 8 months
Secondary	Rate of perioperative blood transfusion	The percentage of red blood, fresh frozen plasma and platelet transfusion	Through study completion,about 8 months
Secondary	Rate of postoperative cardiac complications	Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination	Through study completion,about 8 months
Secondary	Rate of postoperative pulmonary complications	Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination	Through study completion,about 8 months
Secondary	Rate of postoperative neurological complication	Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination	Through study completion,about 8 months
Secondary	Rate of postoperative renal complication	Need renal replacement therapy	Through study completion,about 8 months
Secondary	Other severe complication	Including re-operation, re-admission of intensive care unit, multiple organ dysfunction, all cause death according to physical and laboratory examination and medical record	Through study completion,about 8 months